1. Field of the Invention
The invention relates to security films that are useful for anti-counterfeiting, such as may be employed in pharmaceutical packaging. In particular, the invention pertains to security films and articles having a luminescent composition on or in a polymeric layer that luminesces upon the application of ultraviolet radiation in the 200 nm to 300 nm range, in which the luminescent component is optionally and preferably not viewable to the unaided eye.
2. Description of the Related Art
Product packaging, including labels or tags on products, serve many functions for both manufacturers and consumers. For a manufacturer, one function of product packaging is for advertising. For a consumer, it provides valuable information that helps in the buying decision. As a mutual benefit, product packaging also may serve to protect the product from destructive elements in its surrounding environment. Some product packaging is also used for the additional purpose of ensuring identification and authentication of a product, and protection against product counterfeiting. Today, the counterfeiting of consumer products is a common problem that plagues governments and manufacturers around the world. This is particularly a problem in the pharmaceutical industry, where drug counterfeiters not only defraud consumers, they also deny ill patients the therapies that can alleviate suffering and save lives.
According to the federal Food and Drug Administration (FDA), there has been a recent increase in counterfeiting activities as well as increased sophistication in the methods used to introduce finished dosage form counterfeits into the otherwise legitimate U.S. drug distribution system. FDA counterfeit drug investigations have involved well-organized criminal operations that seek to introduce finished drug products that may closely resemble legitimate drugs yet may contain only inactive ingredients, incorrect ingredients, improper dosages, sub-potent or super-potent ingredients, or be contaminated. Therefore, drug counterfeiting poses real public health and safety concerns today, and may pose an even greater threat in the future. As counterfeiters continue to seek out new technologies to make deceptive products and introduce them into legitimate commerce, systems for protecting patients must respond effectively.
While improvement of the security of consumer products is a recognized need, particularly in the pharmaceutical industry, pharmaceutical companies are often limited due to FDA packaging requirements and the lack of security in current printing operations for the outside package. In a preferred solution, an anti-counterfeiting taggant may be introduced in secure pill production/packaging lines, being placed as close as possible to the drug. However, proximity of taggants to the drug may be restricted by FDA requirements to placement of an impervious plastic film barrier between the taggant and the drug.
Recent advances in the art of security films and articles are described in commonly assigned U.S. patent applications 2003/0194578 and 2002/0160188, which are incorporated herein by reference in their entireties. Application 2003/0194578 teaches security articles comprising elements such as filaments, fibers, including hollow fibers, and threads and thin transverse sections and chopped versions thereof, wherein such elements are dispersed within the articles. Particle scattering and luminescent technology is employed based on scattering, electronic, magnetic and/or light properties to provide compound physical coloration responsive to various portions of the electromagnetic spectrum, including ultraviolet, ambient and infrared. Application 2002/0160188 teaches security articles comprising fibers, threads and fiber sections (“dots”) possessing multiple verification characteristics. The fibers possess unique and difficulty duplicated combinations of complex cross-sections, components, and multiple luminescent responses, and has many verifiable characteristics of the security fibers, threads, and dots that provide high levels of protection against fraudulent duplication of articles in which they are incorporated.
A significant advance in the production of color in articles, including fibers, threads and film, is disclosed in commonly assigned U.S. Pat. No. 5,932,309, which is incorporated herein by reference in its entirety. To achieve coloration, U.S. Pat. No. 5,932,309 utilizes particle scattering effects and/or electronic transition colorants, as defined in the patent. The resulting coloration in an article can be highly stable or responsive to switching effects of, e.g., temperature, thermal exposure, moisture absorption and exposure to actinic radiation. Other efforts include U.S. Pat. No. 6,165,609 which describes labels having a security coating on a substrate that is not transparent to ultraviolet radiation in the 200 nm to 300 nm range. Also, U.S. Pat. No. 5,885,677, et al. describes security labels having a diffusing identifier medium, but also does not teach a substrate that is transparent to radiation in the 200 nm to 300 nm range.
The present invention provides an improved anti-counterfeiting process and construction compared to the related art. The construction of the invention isolates one or more taggants from a product either by placing the taggants between two film layers or by blending the taggants within a polymeric film layer, thus minimizing FDA issues of taggant contact with drugs. Further, the construction of the invention provides improved security by containing one or more taggants that are visible only when exposed to invisible light, or potentially a construction whereby luminescent emissions could also be outside the visible light spectrum, requiring specialized detection equipment. It has been found that Aclar®, a clear fluoropolymer material manufactured by Honeywell International Inc. of Morristown, N.J., is an excellent pharmaceutical packaging material and is unique in that it is transparent to short UV light, i.e. radiation in the 200 nm to 300 nm range, whereas other clear packaging materials are not. Accordingly, security films and articles incorporating Aclar® have been found to be exceptionally effective.